DK3481416T3 - Subkutan administration af langtidsvirkende faktor ix hos mennesker - Google Patents

Subkutan administration af langtidsvirkende faktor ix hos mennesker Download PDF

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Publication number
DK3481416T3
DK3481416T3 DK17742959.4T DK17742959T DK3481416T3 DK 3481416 T3 DK3481416 T3 DK 3481416T3 DK 17742959 T DK17742959 T DK 17742959T DK 3481416 T3 DK3481416 T3 DK 3481416T3
Authority
DK
Denmark
Prior art keywords
people
long
subcutaneous administration
term factor
factor
Prior art date
Application number
DK17742959.4T
Other languages
Danish (da)
English (en)
Inventor
Christine Voigt
Shilpa Puli
John Roberts
Marc Nolte
Original Assignee
CSL Behring Lengnau AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CSL Behring Lengnau AG filed Critical CSL Behring Lengnau AG
Application granted granted Critical
Publication of DK3481416T3 publication Critical patent/DK3481416T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
DK17742959.4T 2016-07-08 2017-07-07 Subkutan administration af langtidsvirkende faktor ix hos mennesker DK3481416T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662359745P 2016-07-08 2016-07-08
PCT/EP2017/067127 WO2018007601A1 (en) 2016-07-08 2017-07-07 Subcutaneous administration of long-acting factor ix in humans

Publications (1)

Publication Number Publication Date
DK3481416T3 true DK3481416T3 (da) 2020-12-14

Family

ID=59388044

Family Applications (1)

Application Number Title Priority Date Filing Date
DK17742959.4T DK3481416T3 (da) 2016-07-08 2017-07-07 Subkutan administration af langtidsvirkende faktor ix hos mennesker

Country Status (11)

Country Link
US (1) US20200093901A1 (enExample)
EP (2) EP3481416B1 (enExample)
JP (1) JP6971301B2 (enExample)
KR (1) KR102446476B1 (enExample)
CN (1) CN109843319A (enExample)
AU (1) AU2017294555B2 (enExample)
CA (1) CA3029887A1 (enExample)
DK (1) DK3481416T3 (enExample)
ES (1) ES2832648T3 (enExample)
PL (1) PL3481416T3 (enExample)
WO (1) WO2018007601A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4362971A1 (en) * 2021-07-01 2024-05-08 CSL Behring Lengnau AG Factor ix subcutaneous administration with enhanced safety

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL113010A (en) 1994-03-31 1999-10-28 Pharmacia & Upjohn Ab Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration
CA2405550A1 (en) * 2000-04-12 2001-10-25 Human Genome Sciences, Inc. Albumin fusion proteins
US7939632B2 (en) 2006-06-14 2011-05-10 Csl Behring Gmbh Proteolytically cleavable fusion proteins with high molar specific activity
CN103140237A (zh) 2010-07-09 2013-06-05 比奥根艾迪克依蒙菲利亚公司 因子ix多肽及其使用方法
TW201427685A (zh) * 2012-09-25 2014-07-16 Biogen Idec Inc Fix多肽的應用
EP3082848B1 (en) * 2013-12-06 2023-10-18 Bioverativ Therapeutics Inc. Population pharmacokinetics tools and uses thereof
CA2934081A1 (en) * 2013-12-23 2015-07-02 Csl Limited Fusion proteins comprising factor ix for prophylactic treatment of hemophilia and methods thereof

Also Published As

Publication number Publication date
CN109843319A (zh) 2019-06-04
AU2017294555B2 (en) 2022-04-28
KR20190026863A (ko) 2019-03-13
AU2017294555A1 (en) 2019-02-21
ES2832648T3 (es) 2021-06-10
EP3481416A1 (en) 2019-05-15
JP6971301B2 (ja) 2021-11-24
US20200093901A1 (en) 2020-03-26
CA3029887A1 (en) 2018-01-11
EP3733199A1 (en) 2020-11-04
KR102446476B1 (ko) 2022-10-19
PL3481416T3 (pl) 2021-03-22
JP2019524089A (ja) 2019-09-05
WO2018007601A1 (en) 2018-01-11
EP3481416B1 (en) 2020-09-09

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